Trial Outcomes & Findings for Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062) (NCT NCT01463683)

Results Overview

Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

722 participants

Primary outcome timeframe

Month 7

Results posted on

2018-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	V232-2XP Subcutaneous (SC) 2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-1XP SC 1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-2XP Intramuscular (IM) 2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
Overall Study STARTED	309	309	104
Overall Study Received Vaccination 1 (Day 1)	309	308	104
Overall Study Received Vaccination 2 (Month 1)	302	300	103
Overall Study Received Vaccination 3 (Month 6)	290	281	93
Overall Study COMPLETED	290	278	93
Overall Study NOT COMPLETED	19	31	11

Reasons for withdrawal

Reasons for withdrawal
Measure	V232-2XP Subcutaneous (SC) 2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-1XP SC 1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-2XP Intramuscular (IM) 2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
Overall Study Adverse Event	2	0	0
Overall Study Lost to Follow-up	10	9	7
Overall Study Physician Decision	0	3	1
Overall Study Pregnancy	2	2	1
Overall Study Withdrawal by Subject	5	17	2

Baseline Characteristics

Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V232-2XP SC n=309 Participants 2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-1XP SC n=308 Participants 1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-2XP IM n=104 Participants 2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6	Total n=721 Participants Total of all reporting groups
Age, Continuous	27.3 Years STANDARD_DEVIATION 4.7 • n=5 Participants	26.8 Years STANDARD_DEVIATION 4.6 • n=7 Participants	26.9 Years STANDARD_DEVIATION 4.9 • n=5 Participants	27.1 Years STANDARD_DEVIATION 4.7 • n=4 Participants
Sex: Female, Male Female	169 Participants n=5 Participants	144 Participants n=7 Participants	48 Participants n=5 Participants	361 Participants n=4 Participants
Sex: Female, Male Male	140 Participants n=5 Participants	164 Participants n=7 Participants	56 Participants n=5 Participants	360 Participants n=4 Participants

PRIMARY outcome

Timeframe: Month 7

Population: The per protocol population consisted of all randomized participants who met enrollment criteria, did not violate the protocol, were seronegative at Baseline, and had vaccination and blood collection. Seroprotection was evaluated only for participants receiving vaccine subcutaneously; intramuscular vaccination was evaluated for safety only.

Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.

Outcome measures

Outcome measures
Measure	V232-2XP SC n=247 Participants 2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-1XP SC n=217 Participants 1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-2XP IM 2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection	90.1 Percentage of participants	82.5 Percentage of participants	—

PRIMARY outcome

Timeframe: Up to 15 days after each vaccination

Population: All randomized participants who received at least 1 vaccination were included in the analysis

Participants were evaluated for injection-site adverse events using MedDRA version 15.1

Outcome measures

Outcome measures
Measure	V232-2XP SC n=309 Participants 2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-1XP SC n=308 Participants 1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-2XP IM n=104 Participants 2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
Percentage of Participants With Injection-site Adverse Events	76.4 Percentage of participants	71.4 Percentage of participants	65.4 Percentage of participants

PRIMARY outcome

Timeframe: Up to 15 days after each vaccination

Population: All randomized participants who received at least 1 vaccination were included in the analysis

Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).

Outcome measures

Outcome measures
Measure	V232-2XP SC n=309 Participants 2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-1XP SC n=308 Participants 1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-2XP IM n=104 Participants 2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
Percentage of Participants With Pyrexia Adverse Events	3.2 Percentage of participants	3.9 Percentage of participants	4.8 Percentage of participants

Adverse Events

V232-2XP SC

Serious events: 1 serious events

Other events: 239 other events

Deaths: 0 deaths

V232-1XP SC

Serious events: 2 serious events

Other events: 225 other events

Deaths: 0 deaths

V232-2XP IM

Serious events: 0 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	V232-2XP SC n=309 participants at risk 2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-1XP SC n=308 participants at risk 1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-2XP IM n=104 participants at risk 2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.32% 1/309 • Number of events 1 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	0.00% 0/308 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	0.00% 0/104 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/309 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	0.32% 1/308 • Number of events 1 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	0.00% 0/104 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination
Surgical and medical procedures Abortion induced	0.00% 0/309 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	0.32% 1/308 • Number of events 1 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	0.00% 0/104 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination

Other adverse events

Other adverse events
Measure	V232-2XP SC n=309 participants at risk 2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-1XP SC n=308 participants at risk 1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6	V232-2XP IM n=104 participants at risk 2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
General disorders Injection-site erythema	55.7% 172/309 • Number of events 294 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	49.4% 152/308 • Number of events 288 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	25.0% 26/104 • Number of events 40 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination
General disorders Injection-site pain	69.9% 216/309 • Number of events 441 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	63.0% 194/308 • Number of events 400 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	59.6% 62/104 • Number of events 120 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination
General disorders Injection-site pruritus	16.2% 50/309 • Number of events 75 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	17.5% 54/308 • Number of events 81 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	4.8% 5/104 • Number of events 6 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination
General disorders Injection-site swelling	53.4% 165/309 • Number of events 278 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	48.4% 149/308 • Number of events 253 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	25.0% 26/104 • Number of events 39 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination
Infections and infestations Nasopharyngitis	3.9% 12/309 • Number of events 12 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	3.9% 12/308 • Number of events 12 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	6.7% 7/104 • Number of events 7 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination
Nervous system disorders Headache	6.8% 21/309 • Number of events 29 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	6.5% 20/308 • Number of events 28 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination	11.5% 12/104 • Number of events 14 • Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination The analysis population for adverse events was participants who received at least 1 vaccination

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER